- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2011-10
2017-08-31
2017-08-31
2
NCT01553019
University of Florida
University of Florida
INTERVENTIONAL
Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer
The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy has on resected pancreatic cancer.
Proton radiation with concomitant chemotherapy
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-10-21 | N/A | 2017-09-01 |
2012-03-09 | N/A | 2017-09-06 |
2012-03-13 | N/A | 2017-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 1- R(0) negative 50.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine | RADIATION: Proton radiation
DRUG: Gemcitabine
|
| EXPERIMENTAL: 2- R(1) micro-positive 54.00 cobalt gray equivalent(CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine | RADIATION: Proton radiation
DRUG: Gemcitabine
|
| EXPERIMENTAL: 3- R(2) gross positive 59.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine | RADIATION: Proton radiation
DRUG: Gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Radiation Toxicity | Assessment of acute/late severe (defined as grade 3-5) radiation toxicity at the completion of therapy. Acute toxicity will be defined to be toxicity occurring within 90 days from the start of radiation treatment, and late toxicity will be defined as toxicity occurring more than 90 days from the start of radiation treatment. | 90 days after completion of RT |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Survival Rate | One year overall survival rate | 1 year after completion of RT |
| Response rate via CA 19-9 | Every 3 months for 2 years, then every 6 months for 3-5 years then annually thereafter |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
